CERSI P.I.s and Collaborators: Eleanor Perfetto, Ph.D., UMB School of Pharmacy; Ester Villalonga Olices, Ph.D., M.Sc., UMB School of Pharmacy
FDA SME and Collaborator: Elektra Papadopoulos, M.D., MPH, CDER
Project Description and Goals
The science of clinical outcomes assessment (COA) is of growing interest and has become important to medical product development. COA involves understanding the patient’s view of illness and treatment, and gathering how the patient feels and functions. To understand if, for example, a treatment improves a patient’s pain, ability to perform daily activities, or quality of life, measures must be rigorous, whether collected from the patient, clinician, or caregiver’s perspectives. Thus, FDA staff and reviewers, and industry staff must be well versed in the science of COA. However, most educational programs on COA are not easily accessible to working professionals.
The objective of this project is to develop and deliver an easily accessible, online continuing education program for clinicians and researchers that introduces learners to the basics of COA. The learners will come from the FDA and other government agencies, industry, consulting companies, and academia. The course will be of benefit to the FDA in that its staff and consultants, and its constituent audiences will be more familiar with COAs as well as the FDA COA guidance, roadmap and other related materials. This proposal describes the content of the program, processes for development and delivery, as well as the budget, timeline, and deliverables. 
Clinical outcomes assessment (COA) focuses on measurement of outcomes based on patients’ direct and others’ reports on patient feeling and function to generate a more complete understanding of patient experiences and outcomes. Training in this area has been largely limited to academic degree programs hosted by universities. This format restricts access for working clinical professionals and government employees. COA training is needed by FDA regulators and reviewers, biopharmaceutical industry staff, and others, but is not available in an accessible, low burden format. 
The objective of the proposed project is to develop and deliver an online COA continuing-education (CE) series that provides an introduction to COA fundamentals in an accessible format. The COA CE series will be geared toward working professionals who seek greater knowledge and skills on the emerging science of COA. Learners will include staff from government agencies (e.g., FDA and CMS), the biopharmacuetical industry, consulting companies and vendors (e.g., clinical research organizations), and academia (faculty and graduate students). They can earn professional CEUs or take as a non-credit course.